FDA Recall of Cytal Wound Matrix Due to Endotoxin Issues
Integra LifeSciences Corp. is recalling 46 units of Cytal Wound Matrix 2-Layer 7x10 cm because of an increased rate of out-of-specification endotoxin results, affecting products distributed nationwide in the United States.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 4, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Integra LifeSciences Corp. is recalling the Cytal Wound Matrix due to an increased rate of out-of-specification endotoxin results.
Which Products Are Affected
The affected product is Cytal Wound Matrix 2-Layer 7x10 cm, with Product ID: WSM0710. It includes UDI-DI: 00386190001448 and Lot Numbers: 7579683, 7582225, 7583893, 7582227, 7583933, 7583891, 7591942, 7591944, 7583935, 7594266, 7594288, 7594286, 7593011, 7594284, 7593013. A total of 46 units are involved, distributed in the states of AL, AZ, CA, DC, FL, GA, IA, IL, KS, KY, LA, MD, ME, MN, MO, MT, NC, ND, NE, NJ, NY, OH, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV.
What You Should Do
Consumers should follow the firm's initial notification, which was a letter, and contact the recalling firm for instructions on the affected products.
Why This Matters
This recall involves medical devices that may not meet safety standards, potentially affecting patient health in the United States.
Source
FDA recall notice Z-1817-2026
Original source: FDA Official Notice ↗
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